Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01578850
First received: April 12, 2012
Last updated: September 10, 2014
Last verified: September 2014

April 12, 2012
September 10, 2014
July 2012
September 2014   (final data collection date for primary outcome measure)
Proportion of subjects who remained in low disease activity at Week 52, among those who have achieved it at Week 24. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01578850 on ClinicalTrials.gov Archive Site
  • Proportion of subjects who remained in remission at Week 52, among those who have achieved remission at Week 24. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects in LDA or remission at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the DAS28 score at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Time-to-flare or loss of efficacy during Period 2. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving European League Against Rheumatism good and or moderate responses at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving LDA or remission at each visit during Period 1 and 2 based on CDAI and SDAI each visit during Period 1 and 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change of CDAI and SDAI at each visit during Period 1 and 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ACR 20, ACR 50, ACR 70 and ACR 90 during Period 1 and Period 2 at each visit. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in the tender and swollen joint counts at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in the Physician Global Assessment at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in the Subject Global Assessment, including morning stiffness (measured in minutes) at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in the Subject General Health visual analog scale, and Pain VAS at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in CRP and ESR at each visit during Period 1 and Period 2. [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
A Randomized, Double-blind Placebo-controlled Study of the Maintenance of Efficacy of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone in Subjects With Rheumatoid Arthritis After Achieving an Adequate Response With Etanercept Plus Dmard(s)

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Etanercept
    etanercept 50mg once weekly + methotrexate with or without other DMARDs
  • Drug: placebo
    etanercept placebo once weekly + methotrexate with or without other DMARDs
  • Experimental: Group A
    Intervention: Drug: Etanercept
  • Placebo Comparator: Group B
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
  2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

Exclusion Criteria:

  1. Subjects who used any of the following systemic treatments during the washout periods given below:

    1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
    2. Treatment with more than 1 NSAID within 14 days at baseline.
    3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
    4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
    5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
  2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
  3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Both
18 Years to 70 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Egypt,   United Arab Emirates,   Lebanon,   Philippines,   Hungary,   Taiwan,   Mexico,   Colombia,   Brazil,   China,   Thailand,   Czech Republic,   Qatar,   Malaysia,   Ukraine,   Russian Federation,   Jordan,   Romania,   South Africa
 
NCT01578850
B1801315
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP